FDA Investigator Ivis L Negron

Ivis L Negron has conducted inspections on 104 sites in 20 countries as of 20 Jun 2023. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
104
Last Inspection Date:
20 Jun 2023
Investigator Role:
FDA Investigation Participant
Redica ID:
Countries of Inspections:
China, Israel, Japan, United Kingdom of Great Britain and Northern Ireland, Puerto Rico, Brazil, Czechia, India, United States of America, Jordan, Italy, France, Taiwan, Singapore, Switzerland, Hungary, Spain, Malta, Ireland, Germany
FDA Investigators that have inspected at least one site in common with Ivis L Negron:
Aaron F Coleman, Adalberto Cajigas, Adaliz Santaliz Cruz, Ademola O Daramola, Agnes M Santori, Alan A Rivera, Alan L Truong, Alan P Kurtzberg, Albert A Salvador, Amanda E Lewin, PhD, Anastasia G Lolas, Anastasia M Shields, Andrea D Charles Julien, Andrea George, PhD, Andrea J Schmidt, Andrew J Mcguffin, Angela E Glenn, Angelica M Hernandez, Anita R Michael, Ann L Demarco, Ann Marie Montemurro, Anna Lazar, Anna M Brannen, Annette Melendez, Anthony J Ladner, Anthony N Onianwa, Ariel Cruz Figueroa, Arindam Dasgupta, PhD, Arlene M Badillo, Arsen Karapetyan, Arwa S El Hagrasy, Ashar P Parikh, Ashley N Queen, PhD, Ashutosh Rao, PhD, Azza Talaat, Barbara J Rincon, Benita C Okeke, Binh T Nguyen, Bo Chi, PhD, Bonita S Chester, Brandon C Heitmeier, Brandy N Lepage, Brenda Rivera, Brenda S Zimmer, PhD, Brenda W Uratani, PhD, Bruce H Mccullough, Brunilda Torres, Calvin B Koerner, Camerson E Moore, Carl Lee, Carla A Norris, Carla J Lundi, Carlos A Medina, Carrie A Hughes, Caryn M Mcnab, CDR Ileana Barreto Pettit, CDR Rochelle B Young, RPh, MSA, Chaoying C Ma, Charisse K Green, Charles I Ann, Charles M Edwards, Charles R Cote, RIC, Chelsea N Sealey, Cheryl A Clausen, Chilton L Ng, Christina Capacci Daniel, PhD, Christopher Downey, PhD, Christopher T Middendorf, Chunsheng Cai, PhD, Colleen Thomas, PhD, Constance Y Fears, Craig D Zagata, Cynthia J Lee, MS, Cynthia M Goudeau, Daniel J Lahar, Daniel J Roberts, David Acevedo, David D Anderson, PhD, David Keire, David M Beltran, David P King, Dayna I Martinez, Debra I Love, Debra J Bennett, Demitria J Xiradakis, Dennis Cantellops Paite, Devaughn Edwards, Dewayne E Whitlock, Diane Kelley, Dipesh K Shah, Donald C Obenhuber, PhD, Donald J Mee, Donald L Lech, Donna Christner, Dorothy P Kramer, Douglas C Kovacs, Dov H Pluznik, PhD, Dr. Barbara D Paul, PhD, Dr. Carmelo Rosa, Dr. Chunchang Fang, Dr. Gang Wang, PhD, Dr. Gopa Biswas, PhD, Dr. Guang Gao, PhD, Dr. Jason R Caballero, Dr. Jun Liu, PhD, Dr. Ralph M Bernstein, PhD, Dr. Robert C Horan, MD, Dr. Sriram Subramaniam, PhD, Dr. Zhihao Qiu (Peter), PhD, Edward H Maticka, Edwin Martinez, Edwin Melendez, Eliezar Ramos, Eric L Dong, BS, Eric M Mueller, PharmD, Erika E Englund, PhD, Erika V Butler, Felix Maldonado, Frances Namuswe, PhD, Francis A Guidry, Frederick F Razzaghi, Frederick L Fricke, Gajendiran Mahadevan, PhD, Gary L Pierce, Gavin T Cua, George J Flynn, Gerald B Seaborn, Jr, German Rivera, Guo Q Shen, Gwyn G Dickinson, Hasan A Irier, PhD, Hector Espinet, Hector Jcolon Torres, Helen B Ricalde, Helen Verdel, Herbert M Corbello, Holly M Scott, Iraida Ortiz, Jacqueline S Warner, James C Maclaughlin, James L Dunnie, Jr, James R Montero, James S Cartwright, Jamie L Dion, Jared P Stevens, Javier O Vega, Jawaid Hamid, Jennifer A Quinones, Jennifer L Huntington, Jennifer Lalama, Jerri Baker, Jessica L Pressley, Jingbo Xiao, Joan M Cantellops Figueroa, Joan T Briones, Joanne E King, Joanne Heim, Joey V Quitania, Jogy George, John D White, John J Bernal, Jolanna A Norton, Jontae D Sanders, Jorge L Gonzalez, Jorge L Guadalupe, Jorge L Lajara, Jose A Lopez, Jose A Moreno, Jose Acruz Gonzalez, José E Meléndez, Jose F Pedro, Jose M Cayuela, Jose M Gonzalez, Jose R Hernandez, Jose R Lopez, Jose Rflores Veguilla, Jose Velez, Joseph R Lambert, Joshua J Silvestri, Juhong Liu, PhD, Julie D Bringger, Junho Pak, Justin A Boyd, Karen A Wolnik, Karen Takahashi, Kari M Johansen, Karl D Hezel, Katey L Gibson, Katherine D Adams, Katherine Szestypalow, Kellia N Hicks, Kelly I Anderson, Kenneth G Klobus, Kenneth H Williams, Kevin A Gonzalez, Kevin P Foley, Kham Phommachanh, Kim Lthomas Cruse, Ko U Min, Kristy A Zielny, Ladner Ladner, Anthony J, Laiza V Garcia, Lance Mde Souza, MBA, Larry K Austin, Laura E Garcia, Laura Fontan, MS, Laurie B Frazier, Laurimer Kuilan Torres, LCDR Michael H Tollon, Leonard H Lavi, Lequita M Mayhew, Lesley K Satterwhite, Libia M Lugo, Linda F Murphy, Linda Thai, Lindsey M Schwierjohann, Lisa M Lopez, Loreily Figueroa Agrinsoni, Lori J Silverstein, Lourdes Andujar, LT Kimberly M Hull, LT Luis O Rodriguez, LT Rafael Gonzalez, Lucas B Leake, Luis A Dasta, Luis Soto Lopez, Lydia I Rosas Marty, Madushini Dharmasena, PhD, Makini Cobourne Duval, PhD, Marcus A Ray, Marcus F Yambot, Margaret M Annes, Margarita Santiago, Maria Gutierrez Lugo, PhD, Maria Joselopez Barragan, PhD, Maria V Price, Marian E Ramirez, Marianela Aponte Cruz, Marie F Morin, Marijo B Kambere, PhD, Mark C Saale, Marlene G Swider, Marvin D Jones, Mary E Farbman, PhD, Mary E Storch, Maryam Tabatabaie, Marybet Lopez Negron, Matthew B Casale, Matthew B Thomaston, Maxwell Van Tassell, PhD, Megan A Haggerty, Megan T Ziegler, Melanie M Walker, Melissa D Ray, Melissa J Garcia, Meredith P Soehl, Investigator, Michael A Charles, Michael A Taylor, Michael J Kuchta, Michael L Casner, Michael R Goga, Michael Shanks, MS, Michael T Cyrus, Michele L Forster, PhD, Michele L Obert, Michele Perry Williams, Michelle Yclark Stuart, Miguel A Martinez Perez, Miguel Hernandez Sanchez, Mihaly S Ligmond, Milva E Melendez Perales, Min Tang, Mindy M Chou, Monica E Caphart, Monica M Mcclure, Mra Davism, Mra M Barbosar, Mra Mcculloughj, Mra Munizn, Muralidhara B Gavini, PhD, Myriam M Sosa, Nadeem I Chaudhry, Nancy Rosado, Nicholas L Hunt, Nicholas L Paulin, Nicholas Obiri, PhD, Nicole E Knowlton, Nije A Thomas, Niketa Patel, Nikki S Ramirez, Nikolay Spiridonov, Noreen Muñiz, Nydia E Colon, Omayra Nrodriguez Ruiz, Omotunde O Osunsanmi, Pablo Feliciano, Paraluman S Leonin, Parul M Patel, Patricia D Stahnke, Patricia F Hughes, PhD, Patrick B Cummings, Patrick C Klotzbuecher, Paul A Bonneau, Paul L Bellamy, Paul L Figarole, Jr, Paul Z Balcer, Paula A Trost, Paula J Bretz, Perry H Gambrell, Peter E Baker, Pratik S Upadhyay, DDC, Rachael L Cook, Rachel C Harrington, Rafael Nevarez Nieves, Rakhi B Shah, Ralph H Vocque, Ramesh Potla, PhD, Ramon A Hernandez, Raquel Gonzalez Rivera, Rebeca M Melendez, Rebecca E Dombrowski, Rebecca Parrilla, Rebecca Rodriguez, Regina T Brown, Reyes Candau Chacon, PhD, Richard E Needham, Richard H Penta, Richard K Vogel, Richard Ledwidge (nmi), PhD, Riley C Myers, PhD, Rita K Kabaso, Robert C Steyert, Robert D Tollefsen, Robert Darius, Robert J Ham, Robert J Martin, Robert M Barbosa, Robert Rodriguez, Robert Sharpnack, Rochelle K Kimmel, Rochelle L Cross, Ruben C Ayala, PharmD, S Lori Brown, PhD MPH, Saied A Asbagh, Saleem A Akhtar, Salvatore N Randazzo, Samina S Khan, Sandra A Hughes, Sangeeta M Khurana, PhD, Sanket N Patel, Santos E Camara, Sarmistha Sanyal, PhD, Scott B Laufenberg, Scott T Ballard, Seneca D Toms, Sharmista Chatterjee, Sharon Giamberini, Sharon K Thoma, PharmD, Sidney B Priesmeyer, Simone E Pitts, Sina Shojaee, Sixto M Mercado Rios, Sneha S Patel, Sonia M Monges, Sony Mathews, Stacie A Woods, Stephen E Langille, Stephen J Koniers, Steven A Brettler, Steven A Gonzales, Steven B Barber, Steven C Madzo, Steven E Bowen, PhD, Steven E Kane, Steven Fong, MS, PhD, Steven J Rush, Steven M Weinman, Steven P Donald, Susan F Laska, MS, Susan M Jackson, Susan P Bruederle, Susanna E Ford, Syed N Ali, Tara G Bizjak, Teresa I Navas, Terri L Dodds, Thai T Duong, Thao T Kwan, Thomas J Arista, Thomas W Gordon, Thuy T Nguyen, LCDR, Tiara Nbrown Crosen, Tiffani D Wilson, Timothy T Kapsala, Timothy Wadkin, PhD, Todd M Stankewicz, Tonya R Johnson, Torrance J Slayton, Tracy K Li, Tricia S Martinez, Truong Xuan Nguyen (Andy), Uduak M Inokon, Unnee Ranjan, Uttaniti Limchumroon (Tom), Vaishali J Patel, Valerie L Whipp, Victor J Gangi, Vilmary Negron Rodriguez, Viviana Matta, Wanda J Torres, Warren J Lopicka, Wayne D Mcgrath, Wei Hua Emily Wu, Wendy G Tan, PhD, William A Warnick, William Hallett, PhD, William J Leonard, Xiaokuang Lai, PhD, Xiaoping Guan, Yeissa Chabrier Rosello, Ying Xin Fan, PhD, Youkeun Kim, Yumi J Hiramine, Yvins Dezan, Zachary A Bogorad, Zachary L Miller, Zachary L Stamm, Zhaoyang Meng, Zhong Li, PhD, Zhongren Wu, Zi Qiang Gu

Ivis L Negron's Documents

Publish Date Document Type Title
August, 2014 FDA 483 Nantong Tianlong Animal By-products Co., Ltd - Form 483, 2014-08-08
July, 2021 EIR Caribe Holdings (Cayman) Co.ltd. DBA PuraCap Caribe - EIR, 2021-07-02
May, 2009 FDA 483 APP Pharmaceuticals, LLC. - Form 483, 2009-05-28
January, 2017 FDA 483 SOFGEN PHARMACEUTICALS LLC - Form 483, 2017-01-20
May, 2016 EIR Patheon Italia S.p.A - EIR, 2016-05-20
May, 2011 FDA 483 Asymchem Life Science (Tianjin) Co., Ltd. - Form 483, 2011-05-18
June, 2001 FDA 483 Schering-Plough Products LLC - Form 483, 2001-06-13
July, 2010 FDA 483 YUKI GOSEI KOGYO CO., LTD. - Form 483, 2010-07-21
April, 2002 EIR Lonza AG - EIR, 2002-04-29
October, 2012 FDA 483 Caribe Holdings (Cayman) Co.ltd. DBA PuraCap Caribe - Form 483, 2012-10-22
April, 2001 EIR Charles River Laboratories Edinburgh Ltd. - EIR, 2001-04-05
February, 2000 EIR Janssen Ortho LLC - EIR, 2000-02-18
February, 2010 FDA 483 HILL DERMACEUTICALS, INC. - Form 483, 2010-02-19
February, 2009 FDA 483 Auro PR Inc. - Form 483, 2009-02-27
July, 2019 FDA 483 Dexcel Pharma Technologies - Yokneam Factory - Form 483, 2019-07-17
February, 2000 FDA 483 Janssen Ortho LLC - Form 483, 2000-02-18
March, 2009 FDA 483 Pfizer Pharmaceuticals LLC - Form 483, 2009-03-25
March, 2020 FDA 483 Caribe Holdings (Cayman) Co.ltd. DBA PuraCap Caribe - Form 483, 2020-03-10
April, 2002 FDA 483 Lonza AG - Form 483, 2002-04-29
January, 2004 FDA 483 Response Teva Pharmaceutical Works Private Limited Company - Form 483R, 2004-04-09
November, 2003 EIR Northeast Pharmaceutical Group Co., Ltd. - EIR, 2003-12-02
October, 2001 FDA 483 Kongo Chemical Co. LTD - Form 483, 2001-10-17
February, 2020 FDA 483 AbbVie Ltd - Form 483, 2020-02-20
July, 2019 FDA 483 Dexcel Ltd. - Form 483, 2019-07-24
October, 2012 EIR Caribe Holdings (Cayman) Co.ltd. DBA PuraCap Caribe - EIR, 2012-10-22
November, 2003 EIR Shanghai Ziyuan Pharmaceutical Co. Ltd. - EIR, 2003-11-24
September, 2012 FDA 483 Gland Pharma Limited - Form 483, 2012-09-07
August, 2015 FDA 483 Nephron Pharmaceuticals Corporation - Form 483, 2015-08-14
October, 2001 FDA 483 Yuki Gosei Kogyo Co. LTD - Form 483, 2001-10-12
September, 2017 FDA 483 Bristol-Myers Squibb Holdings Pharma, Ltd. Liability Company - Form 483, 2017-09-11
September, 2007 FDA 483 Syn-Tech Chem. & Pharm. Co., Ltd - Form 483, 2007-09-20
September, 2022 FDA 483 RAPHA HEALTH NETWORK INTERNATIONAL INC - Form 483, 2022-09-09
April, 2001 FDA 483 Response Charles River Laboratories Edinburgh Ltd. - Form 483R, 2001-05-23
October, 2008 FDA 483 IPR Pharmaceuticals, Inc - Form 483, 2008-10-27
July, 2019 FDA 483 Bio-Technology General (Israel) Ltd. - Form 483, 2019-07-11
April, 2002 FDA 483 Response Lonza AG - Form 483R, 2002-05-02
August, 2014 FDA 483 Changzhou Qianhong Bio Pharma Co., Ltd formulation plant - Form 483, 2014-08-01
April, 2001 FDA 483 Charles River Laboratories Edinburgh Ltd. - Form 483, 2001-04-05
August, 2012 FDA 483 Fresenius Kabi Oncology Limited - Form 483, 2012-08-28
February, 2002 EIR Bristol-Myers Squibb Manufacturing Company Unlimited Company - EIR, 2002-02-28
March, 2016 FDA 483 AbbVie Biotechnology LTD - Form 483, 2016-03-24
July, 2021 FDA 483 Caribe Holdings (Cayman) Co.ltd. DBA PuraCap Caribe - Form 483, 2021-07-02
July, 2021 FDA 483 Response Caribe Holdings (Cayman) Co.ltd. DBA PuraCap Caribe - Form 483R, 2021-07-26
August, 2022 FDA 483 Miramar Cosmetics, Inc DBA Miramar Lab - Form 483, 2022-08-31
September, 2013 FDA 483 Minakem Beuvry Production - Form 483, 2013-09-13
January, 2004 EIR Teva Pharmaceutical Works Private Limited Company - EIR, 2004-03-25
November, 2003 FDA 483 Response Shanghai Ziyuan Pharmaceutical Co. Ltd. - Form 483R, 2004-01-26
July, 2023 FDA 483 Response Amgen Manufacturing Limited LLC - Form 483R, 2023-07-19
July, 2023 FDA 483 Amgen Manufacturing Limited LLC - Form 483, 2023-07-05
May, 2009 FDA 483 Baxter Healthcare Corporation - Form 483, 2009-05-14

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